Phase 4
N=68
Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
Spinal Anesthesia · Cesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT02369510 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Sensory Recovery — 135; 165; 120 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Low-dose epinephrine (Drug); High-dose epinephrine (Drug); No epinephrine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensory Recovery |
135; 165; 120 | — |
| SECONDARY Motor Recovery |
150; 172; 120 | — |
| SECONDARY Block Onset |
6; 8; 8 | — |
| SECONDARY Number of Participants With Hypotension |
5; 2; 8; 3; 9; 3 | — |
| SECONDARY Adequacy of Anesthesia |
0; 0; 0 | — |
| SECONDARY Patient Satisfaction |
90; 85; 87 | — |
| SECONDARY Incidence of Nausea and Vomiting |
2; 0; 4; 3; 6; 1 | — |
| SECONDARY Incidence of Pruritus |
— | — |
Summary
The purpose of this study is to investigate whether the addition of a medication called epinephrine to spinal medications prolongs the duration of the anesthesia. The medication standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain medication (morphine). These medications typically last about 2 hours. The investigators want to determine if adding epinephrine to the spinal medications prolongs the anesthetic without side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean section. Epinephrine is known to prolong the action of some local anesthetics, but the investigators want to specifically study combining it with the medications the investigators use regularly for cesarean section.
You may qualify to take part in this research study because you are having a repeat cesarean section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want to determine if epinephrine will prolong the anesthetic.
Eligibility Criteria
Inclusion Criteria
- Non-emergent repeat cesarean section
- Neuraxial anesthesia as the planned primary anesthetic
- Informed consent obtained
- Females age 18-50
Exclusion Criteria
- Emergency cesarean section
- Anesthetic other than neuraxial
- Allergy to local anesthetics, morphine, or epinephrine
- Pre-existing sensory/motor deficit
Data sourced from ClinicalTrials.gov (NCT02369510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.